Home NDC 63629-3998 Glyburide and Metformin
Product NDC 63629-3998
11-digit product format 636293998
Labeler code 63629
Product ID 63629-3998_faebe298-576b-4bf9-a9f2-c87bceba0f8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glyburide and Metformin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076345
Marketing category ANDA
Marketing start 2007-06-14
Marketing end 0000-00-00
Substance GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength 1 mg/1; mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3998-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-3998-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-3998-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-3998-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-3998-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-3998-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-3998-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-3998-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-3998-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-3998-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-3998-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-3998-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-3998-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-3998-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076345-002 GLYBURIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2004-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076345-003 GLYBURIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2004-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076345-001 GLYBURIDE AND METFORMIN HYDROCHLORIDE 1.25MG;250MG TABLET / ORAL AB 2004-02-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLYBURIDE ACTIVE INGREDIENT SX6K58TVWC GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 GLYBURIDE ACTIVE MOIETY SX6K58TVWC GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 METFORMIN ACTIVE MOIETY 9100L32L2N GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GLYBURIDE AND METFORMIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000